Pediacare Childrens Grape

Product NDC
52412-901
11-digit product format
524120901
Labeler code
52412
Product ID
52412-901_2a810efe-646a-f310-e063-6394a90ab074
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-03
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pediacare Childrens Grape
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9d531a2-234c-4feb-8f05-212dbee83dfeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-901-04Pediacare Childrens Grape118 mL in 1 BOTTLESUSPENSION1182
52412-901-04Pediacare Childrens Grape1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-901PEDIACARE CHILDRENS GRAPE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH]2Current NDC, Legacy NDC, 2 package rows20250101_f9d531a2-234c-4feb-8f05-212dbee83dfe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 72 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668acetaminophen 32 MG/ML Oral SuspensionSCDf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYf9d531a2-234c-4feb-8f05-212dbee83dfe2
307668APAP 32 MG/ML Oral SuspensionSYf9d531a2-234c-4feb-8f05-212dbee83dfe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-901-04524120901041 BOTTLE in 1 CARTON (52412-901-04) / 118 mL in 1 BOTTLE1 bottle2023-01-030000-00-00NoNoCurrent